An AE is considered serious if it p

An AE is considered serious if it poses a threat to the patient’s life or functioning. The U.S. Food and Drug Administration (FDA) defines a serious adverse event (SAE) as any untoward medical occurrence that:
Results in death, or
Places the patient at risk of death, or
Requires hospitalization or prolongs an existing hospitalization, or
Causes persistent or significant disability or incapacity, or
Is a birth defect, or
Requires medical intervention to prevent one of the above outcomes.